Regulatory Matters. The parties will negotiate in good faith to resolve regulatory criticisms or concerns expressed by the Office of the Comptroller of the Currency or other U.S. federal or state banking Regulators that can reasonably be addressed through a modification of the Agreement or adoption of mutually agreeable policies or procedures to prevent or resolve a Material Default described by clause (iii) of such definition, subject to applicable legal requirements including restrictions on disclosing confidential supervisory information.
Regulatory Matters. (a) The parties hereto shall cooperate with each other and use their reasonable best efforts to promptly prepare and file all necessary documentation, to effect all applications, notices, petitions and filings, and to obtain as promptly as practicable all permits, consents, approvals and authorizations of all third parties and Governmental Entities which are necessary or advisable to consummate the transactions contemplated by this Agreement and the Bank Merger Agreements (including without limitation the Merger and the Bank Merger). Camden, KSB and the Bank shall have the right to review in advance, and to the extent practicable, each will consult the other on, in each case subject to applicable laws relating to the exchange of information, all the information relating to either of them, as the case may be, and any of their respective subsidiaries, which appear in any filing made with, or written materials submitted to, any third party or any Governmental Entity in connection with the Merger, the Bank Merger and the other transactions contemplated by this Agreement and by the Bank Merger Agreements. In exercising the foregoing right, each of the parties hereto shall act reasonably and as promptly as practicable. The parties hereto agree that they will consult with each other with respect to the obtaining of all permits, consents, approvals and authorizations of all third parties and Governmental Entities necessary or advisable to consummate the Merger, the Bank Merger and other transactions contemplated by this Agreement and the Bank Merger Agreements and each party will keep the other apprised of the status of matters relating to the completion of all of the transactions contemplated hereby.
(b) Camden, KSB, CASI and the Bank shall, upon request, furnish each other with all information concerning themselves, their respective subsidiaries, directors, officers and stockholders and such other matters as may be reasonably necessary or advisable in connection with any statement, filing, notice or application made by or on behalf of Camden, KSB, CASI, the Bank or any of their respective subsidiaries to any Governmental Entity in connection with the Merger, the Bank Merger or the other transactions contemplated by this Agreement and the Bank Merger Agreements.
(c) Camden, KSB, CASI and the Bank shall promptly furnish each other with copies of written communications received by Camden or KSB, as the case may be, or any of their respective subsidiaries, affiliate...
Regulatory Matters. (a) Subject to Section 4.4, the Stockholder shall, and shall use their reasonable best efforts to cause their Affiliates to, use their reasonable best efforts, consistent with the time frames set forth in Section 6.4 of the Merger Agreement, to supply and provide information that, to such Stockholder’s knowledge, is complete and accurate in all material respects to any Governmental Authority requesting such information in connection with filings or notifications under, or relating to, applicable laws that are required or advisable as a result of, or pursuant to, the Merger Agreement and the related financings and transactions, including, without limitation, information required or requested to be provided to any antitrust, financial or national security regulatory authorities in connection with any approvals reasonably sought in connection with the consummation of the Merger (collectively, the “Regulatory Filings” and the, “Regulatory Disclosures”, respectively). If any Governmental Authority seeks to prevent the consummation of the transactions contemplated by the Merger Agreement based on the HSR Act or any other Antitrust Laws or based on any other required approval, consent, notice or filing with a Governmental Authority and such actions by the Governmental Authority relate to the activities or investments of such Stockholder or its Affiliates (solely for purposes of this Section 4, an “Affiliate” of the Stockholder shall include any portfolio company in which such Stockholder or any of its Affiliates has made a debt or an equity investment), then if Parent in good faith reasonably determines that such actions by the Governmental Authority will not be resolved sufficiently in advance of the Termination Date, Parent may provide written notice of that determination to the Stockholder, and Parent may elect to terminate the obligations under Section 2 and Section 4.6 of this Agreement (in which case the Stockholder’s obligations under the Equity Commitment Letter shall also automatically terminate) and, in that context, the Stockholder shall be entitled to receive the Per Share Price under the Merger Agreement with respect to its shares of Common Stock; provided, however that Parent shall not terminate the Equity Commitment Letter or the obligations under Section 2 of this Agreement pursuant to this Section 4.3(a) without first obtaining alternative financing arrangements which provide Parent with funds in an amount equal to the Rollover Amount; provided t...
Regulatory Matters. (a) FSIC and CCT shall as promptly as practicable, but in no case later than five (5) Business Days after the date of this Agreement, jointly prepare and file with the SEC the Registration Statement. Each of FSIC and CCT shall use its reasonable best efforts to have the Registration Statement declared effective under the Securities Act as promptly as practicable after such filing and to keep the Registration Statement effective as long as necessary to consummate the Mergers. CCT and FSIC shall use reasonable best efforts to cause the Joint Proxy Statement/Prospectus to be promptly mailed or delivered to their respective stockholders upon such effectiveness. FSIC shall also use its reasonable best efforts to obtain all necessary state securities Law or “blue sky” permits and approvals required to carry out the Transactions, if any, and CCT shall use reasonable best efforts to furnish all information concerning CCT and the holders of CCT Common Stock as may be reasonably requested by FSIC in connection with any such action.
(b) Each of FSIC and CCT shall cooperate with the other in the preparation of the Registration Statement and shall furnish to the other all information reasonably requested as may be reasonably necessary or advisable in connection with the Registration Statement or any other filing or application made by or on behalf of FSIC, CCT or any of their respective Consolidated Subsidiaries to any Governmental Entity in connection with the Mergers and the other Transactions. Prior to the Effective Time, each party hereto shall promptly notify the other party (i) upon becoming aware of any event or circumstance that is required to be described in an amendment to the Registration Statement or in a supplement to the Joint Proxy Statement/Prospectus and (ii) after the receipt by it of any comments of the SEC with respect to the Joint Proxy Statement/Prospectus or the Registration Statement.
(c) Subject to applicable Law, each of FSIC and CCT shall promptly advise the other upon receiving any communication from any Governmental Entity, the consent or approval of which is required for consummation of the Transactions, that causes such party to believe that there is a reasonable likelihood that any Regulatory Approval will not be obtained or that the receipt of any such approval may be materially delayed or conditioned.
Regulatory Matters. (a) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect or that, individually or in the aggregate, would not reasonably be expected to prevent, materially delay or materially impair the ability of the Company to perform its obligations under this Agreement or to consummate the Mergers, (i) each of Parent and its Subsidiaries holds (A) all authorizations under the FDCA, the PHSA, and the regulations of the FDA promulgated thereunder, and (B) authorizations of any applicable Governmental Authority that are concerned with the quality, identity, strength, purity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of any of the Parent Products (any such Governmental Authority, a “Parent Regulatory Agency”) necessary for the lawful operation of the businesses of Parent or any of its Subsidiaries as currently conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent and its Subsidiaries are in compliance with the terms of all Parent Regulatory Permits. All Parent Regulatory Permits are in full force and effect, except where the failure to be in full force and effect (A) has not had, and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect or (B) individually or in the aggregate, would not reasonably be expected to prevent, materially delay or materially impair the ability of Parent to perform its obligations under this Agreement or to consummate the Mergers (in the case of this clause (B), as of the date of this Agreement).
(b) Neither Parent nor any of its Subsidiaries are party to any material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders or similar agreements with or imposed by any Parent Regulatory Agency that have had or would reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) All pre-clinical and clinical investigations in respect of a Parent Product conducted or sponsored by Parent or any of its Subsidiaries are being, and since January 1, 2019 have been, conducted in compliance with all Applicable Laws administered or issued by the applicable Parent Regulatory Agencies, including (i) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical t...
Regulatory Matters. (a) All existing Registrations held by Reliant as of the date of this Agreement are set forth in Schedule 1.1.102. Reliant is the sole and exclusive owner of the Registrations. Reliant has delivered to the Purchaser true and correct copies of the Registrations and has made available to the Purchaser copies of material written communications between Reliant, on the one hand, and the FDA or any other applicable Medical Product Regulatory Authority, on the other hand, since October 11, 2000 (the “Reliant Acquisition Date”), and any existing written summaries of material discussions between Reliant and the FDA or any other applicable Medical Product Regulatory Authority since the Reliant Acquisition Date, including, without limitation, copies of (i) all warning letters, FD-483s, notices of adverse findings and similar correspondence received by Reliant from the FDA since the Reliant Acquisition Date, (ii) all audit reports relating to audits for compliance with the Act performed since the Reliant Acquisition Date and submitted to the FDA; (iii) any document concerning any significant oral or written communication received from the FDA by Reliant (whether directly or via any third party) since the Reliant Acquisition Date; and (iv) any written notification from the FDA or any other applicable Medical Product Regulatory Authority indicating that the Product is misbranded or adulterated as defined in the Act. Reliant has delivered any of the foregoing materials sent to or received by the third party manufacturer of the Product that are currently in Reliant’s possession.
(b) The promotion, distribution, marketing and sale and, to Reliant’s Knowledge, manufacture of the Product in the Territory has been conducted in compliance with the Registrations and all applicable Laws, including the Act and the PDM Act. The Registrations required for the manufacturing, promotion, marketing, sale and distribution of the Product in the Territory are in full force and effect.
(c) There are no proceedings pending against Reliant or, to Reliant’s Knowledge, threatened which could result in the revocation, cancellation or suspension of any Registrations listed in Schedule 1.1.102.
(d) Reliant is in compliance in all material respects with all Laws applicable to the ownership, operation, storage, distribution, marketing, pricing, sale, promotion, warehousing, packaging, labeling, handling and/or testing of the Product and the Acquired Assets and, to the Knowledge of Reliant, has not ...
Regulatory Matters. (a) The parties hereto shall cooperate with each other and use commercially reasonable efforts to promptly prepare and file as soon as practicable after the date hereof all necessary documentation, to effect all applications, notices, petitions and filings, and to obtain as promptly as practicable all permits, consents, approvals and authorizations of all third parties, Regulatory Agencies and Governmental Entities which are necessary or advisable for such party to consummate the transactions contemplated by this Agreement (including, without limitation, the Merger and the Bank Merger). The Seller and the Buyer shall have the right to review in advance all such applications, notices, petitions, and filings, and each will consult with the other on, in each case subject to applicable laws relating to the exchange of information, all the information relating to the Buyer, the Buyer Bank, the Seller or the Seller Bank, as the case may be, and any of their respective Subsidiaries, which appear in any filing made with or written materials submitted to, any third-party or any Governmental Entity in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto shall act reasonably and as promptly as practicable. The parties hereto agree that they will consult with each other with respect to the obtaining of all permits, consents, approvals and authorizations of all third parties and Governmental Entities necessary or advisable to consummate the transactions contemplated by this Agreement and each party will keep the other apprised of the status of matters relating to the completion of the transactions contemplated hereby.
(b) The Seller and the Buyer shall, upon request, furnish each other with all information concerning themselves, their Subsidiaries, directors, officers and stockholders and such other matters as may be reasonably necessary or advisable in connection with any statement, filing, notice or application made by or on behalf of the Seller, the Buyer or any of their respective Subsidiaries to any Governmental Entity in connection with the Merger, the Bank Merger and the other transactions contemplated by this Agreement.
(c) The Seller and the Buyer shall promptly furnish each other with copies of written communications received by the Seller or the Buyer, as the case may be, or any of their respective Subsidiaries, "affiliates" or "associates" (as such terms are defined in Rule 12b-2 unde...
Regulatory Matters. (i) The Company, its Affiliates and, the contract research organizations engaged to perform clinical trials on behalf of the Company (the “CROs”) have obtained all Governmental Approvals required by any Governmental Entity, including the FDA, to permit the conduct of the Business and all such Governmental Approvals are valid and in full force and effect, and no such Governmental Approval has been or is being revoked or challenged. Neither the Company, nor to the Knowledge of the Company, any CRO, has received any communication from any Governmental Entity regarding, any such Governmental Approvals, any failure to materially comply with applicable Laws or any term or requirement of any such Governmental Approval, or any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any such Governmental Approval. To the Knowledge of the Company, there are no facts or circumstances that are reasonably likely to adversely affect any such Governmental Approvals. The Company, and to the Knowledge of the Company, the CROs, have filed with the applicable Governmental Entities, including the FDA, all filings, representations, declarations, listings, and registrations, as well as all reports or submissions required under the FDCA and the Public Health Service Act of 1944, as amended, and their implementing regulations, as well as adverse event reports and all other submitted data relating to the Product required to be filed or submitted to permit the conduct of the Business. All such filings, representations, declarations, listings, registrations, reports and submissions were in material compliance with applicable Laws when filed, and no material deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, representations, declarations, listing, registrations, reports or submissions.
(ii) All nonclinical and clinical investigations conducted or sponsored by or on behalf of the Company, and all manufacturing operations, both with respect to the Product, are being, and have been since the Company’s formation, conducted in material compliance with applicable Laws, including, but not limited to the FDCA, good clinical practice requirements, good laboratory practice requirements, GMP, ICH principles and Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (“HIPAA”) and other legal requirements restricting the use and disclosure of individually...
Regulatory Matters. (a) Parent and Subject Company shall promptly prepare and file with the SEC a preliminary version of the Joint Proxy Statement and, following comment thereon, Parent shall promptly prepare and file with the SEC the S-4, in which the definitive Joint Proxy Statement will be included as a prospectus. Each of Parent and Subject Company shall use all reasonable efforts to have the S-4 declared effective under the Securities Act as promptly as practicable after such filing, and Parent and Subject Company shall thereafter mail the definitive Joint Proxy Statement to their respective stockholders. Parent shall also use all reasonable efforts to obtain all necessary state securities law or "Blue Sky" permits and approvals required to carry out the transactions contemplated by this Agreement, and Subject Company shall furnish all information concerning Subject Company and the holders of Subject Company Capital Stock as may be reasonably requested in connection with any such action.
(b) The parties hereto shall cooperate with each other and use reasonable best efforts to promptly prepare and file all necessary documentation, to effect all applications, notices, petitions and filings, to obtain as promptly as practicable all permits, consents, approvals and authorizations of all third parties and Governmental Entities which are necessary or advisable to consummate the transactions contemplated by this Agreement (including without limitation the Merger), and to comply with the terms and conditions of all such permits, consents, approvals and authorizations of all such Governmental Entities. Parent and Subject Company shall have the right to review in advance, and to the extent practicable each will consult the other on, in each case subject to applicable laws relating to the exchange of information, all the information relating to Subject Company or Parent, as the case may be, and any of their respective Subsidiaries which appear in any filing made with, or written materials submitted to, any third party or any Governmental Entity in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto shall act reasonably and as promptly as practicable. The parties hereto agree that they will consult with each other with respect to the obtaining of all permits, consents, approvals and authorizations of all third parties and Governmental Entities necessary or advisable to consummate the transactions contemplated...
Regulatory Matters. The preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the Prospectus (the “Company Studies and Trials”) were, or if still pending are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Co...
